Comparison of Erector Spinae Plane Block and Rectus Sheath Block

Not Applicable

Completed

• Conditions: Postoperative Pain, Acute
• Interventions: Other: bupivacaine

• Registration Number: NCT05225766
• Lead Sponsor: Uludag University

Brief Summary

In study, The investigators aimed to compare the intraoperative and postoperative analgesic efficacy of erector spinae plane block and rectus sheath block, which investigators routinely perform in surgeries with abdominal lover midline-upper midline incision, morphine consumption with patient-controlled analgesia, as well as patient and surgeon satisfaction.

Detailed Description

Following ethics committee approval and written consent from the patients, the study was conducted on 60 patients aged between 18-75 years in American Society of Anesthesiologists (ASA) classes I-III, who were to undergo midline incisions. The demographic data of the patients were recorded and after routine monitoring and general anesthesia induction, they were divided into two groups as the ESPB group and RSB group. Hemodynamic data of all patients were recorded before induction, one minute after induction, and intraoperatively in 30-minute periods. Patient-controlled analgesia (PCA) prepared with morphine was administered to all patients. Patients' intraoperative hemodynamic data and administered opioid doses, postoperative visual analog scales (VAS) at rest and during coughing, time to first PCA dose, postoperative morphine consumption, need for rescue analgesics, duration time until first mobilization, opioid side effects, and patient and surgeon satisfaction were evaluated.

Study Timeline

• Study Start: 2021-02-25
• Primary Completion: 2021-08-11
• Study Completion: 2021-09-09
• Study First Submitted: 2021-11-08
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-02
• Last Update Submitted: 2022-02-02
• Study First Posted: 2022-02-07
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Aged 18-75 years
• American Society of Anesthesiologists (ASA) classes I-III

Exclusion Criteria

• Local anesthetic allergy
• Coagulopathy
• Injection site infection
• History of abdominal surgery
• Severe neurological or psychiatric disorder
• Severe cardiovascular disease, liver failure, renal failure (glomerular filtration rate <15 ml/min/1.73 m2)
• chronic opioid use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group RSB	bupivacaine	Rectus sheath block
Group ESPB	bupivacaine	Erector spinae plane block

Primary Outcome Measures

Name	Time	Method
postoperative morphine consumption	48 hours	Total morphine (mg) consumptions used with postoperative PCA were recorded and compared between groups.
opioid side effects	48 hours	Side effects (nausea, vomiting and sedation) that may occur due to opioid use in patients were recorded. And it was investigated whether there was a difference between the groups.
need for rescue analgesics	48 hours	Bolus-dose morphine administration was provided to patients with VAS ≥4 upon questioning in the clinic or in line with patients' complaints, and patients' VAS scores during the first use of PCA were recorded. It was planned for rescue analgesic to be administered in patients with VAS ≥4 despite PCA, firstly as 20 mg IV tenoxicam (Tilcotil®, Deva, Tekirdağ, Turkey), and secondly as 50 mg IV tramadol (Tramosel®, Haver, Istanbul, Turkey) if VAS was still ≥4 one hour after tenoxicam administration.
postoperative visual analog scales at rest and during coughing	48 hours	Postoperatively, both coughing and resting visual analog scale values (A rating between 0 and 10 was made. 0 no pain 10 severe pain) of the patients were recorded and compared between the groups.
time to first patient controlled analgesia (PCA) dose	48 hours	The times when patients used the PCA device for the first time were recorded and compared between groups.
duration time until first mobilization	48 hours	The times until the first mobilization of the patients were recorded and it was investigated whether there was a difference between the groups in terms of mobilization times.
intraoperative hemodynamic data and administered opioid doses	150 minutes	Intraoperative hemodynamic values (peripheric oxigen saturation, mean arterial pressure, heart rate) of the patients and intraoperative opioid consumption (mg) were compared.
patient and surgeon satisfaction	48 hours	Patient and surgical team satisfaction were recorded using a 5-point Likert scale (A rating of 1 to 5 was requested. 1- not at all satisfied 2- somewhat satisfied 3- undecided 4- satisfied 5- very satisfied).The difference between the groups was investigated.

Trial Locations

Locations (1)

Bursa Uludag University; 🇹🇷 Bursa, Nilüfer, Turkey